Graft fixation device

ABSTRACT

A graft fixation device combination. The device is useful for affixing a tissue graft to a bone or other body surface. The fixation device has two implantation members connected by a graft retention member. The retention member optionally has at least one lateral wing member extending therefrom. The implantation members have longitudinal passageways therethrough. The graft fixation device also has an insertion member extending from the distal end of each implantation member, the insertion member having a longitudinal passage having a distal blind wall. The passages of the implantation members and the insertion members are in communication with each other, and may be mounted onto insertion members.

[0001] This is a Continuation-In-Part application of commonly assignedco-pending U.S. patent application Ser. No. 09/793,036 filed on Feb. 26,2001 which is a Continuation-In-Part application of commonly-assigned,copending U.S. patent application Ser. No. 09/535,183 filed on Mar. 27,2000 which is a Continuation-In-Part of commonly-assigned, copendingpatent application U.S. patent application Ser. No. 09/360,367 filed onJul. 23, 1999, which are incorporated by reference.

TECHNICAL FIELD

[0002] The field of art to which this invention relates is surgicalfastening devices, in particular, surgical fastening devices forfixating tissue grafts to bone.

BACKGROUND OF THE INVENTION

[0003] The medical technology associated with tissue engineering hasadvanced at a rapid pace. In particular, it is now known to harvestcells from the human body, for example, chondrocytes andfibrochrondrocytes from the knee joint. These autologous cells are thencultured in a laboratory environment on a bioabsorbable matrix. Thematrix will typically have a shape substantially similar to the tissuesection which needs to be replaced. After a sufficient period of time inan appropriate culture medium at the proper environmental conditions,the harvested cells will grow on the matrix to form an implantablesection of tissue having substantially the same physical configurationas the section of tissue which needs to be replaced in the patient. Sucha tissue-engineered construct, consisting of cells on the matrix (or,alternatively, consisting of a matrix alone without cells), is thenaffixed to the bone site using conventionally known surgical fastenersincluding sutures, periosteal coverings, or fibrin glue.

[0004] The advantages of tissue engineering are many, not the least ofwhich is, for example, that it is now possible to replace cartilage withliving cartilage tissue. In addition, the likelihood of rejection of thetissue implant is minimized since the cartilage tissue which has beengrown in-vitro is identical to the autologous cartilage of the patient.

[0005] Although existing matrix fixation devices are adequate for theirintended use, there are also some disadvantages attendant with theiruse. First of all these fixation devices are generic in the sense thatthey are not specifically designed for matrix fixation to bone or softtissue, but can be used for a variety of surgical procedures. Otherdisadvantages include the difficulty in using many of these devices in aminimally invasive arthroscopic procedure. Additional disadvantagesinclude the difficulty and surgical challenge of harvesting a piece ofperiosteum for use as a periosteal flap, the significant patientmorbidity associated with such harvesting, and the difficulty insuturing such a thin, compliant material to surrounding tissue.

[0006] Accordingly, there is a need in this art for novel fixationdevices that will effectively affix a matrix of tissue-engineered tissueto a bone or other anchoring site so that the tissue may continue togrow and regenerate in the patient's body.

DISCLOSURE OF THE INVENTION

[0007] Therefore, it is an object of the present invention to provide afixation device that effectively fixates a tissue-engineered matrix to abone or other anchoring site, thereby enabling the implanted matrix toremain in place while the tissue continues to grow and regenerate.

[0008] It is a further object of the present invention to provide such adevice for fixating a matrix to a bone site which is easily installedusing an arthroscopic procedure or an open procedure.

[0009] It is yet a further object of the present invention to providesuch a device for fixating a matrix to a bone site which does notrequire sutures or suture knot tying.

[0010] It is still yet a further object of the present invention toprovide a surgical method for fixating a matrix utilizing such a devicein a location within a patient's body.

[0011] Accordingly, a graft fixation device is disclosed. The graftfixation device has first and second implantation members. The membersare elongated and preferably have a cylindrical configuration. Themembers also have distal ends, proximal ends, and longitudinal axes.There are longitudinal passages extending through the entire length ofeach implantation member. The members have outer surfaces. Theimplantation members are connected to each other by a rod member havingfirst and second ends and a central section. The first end of the rodmember extends from the proximal end of the first implantation memberand the second end of the rod member extends from the proximal end ofthe second implantation member. The rod member is preferably relativelyrigid and may be configured to have a variety of geometric shapes, forexample, an inverted “U” shape. However, the rod member may also beflexible. The rod member maintains the implantation members at arelatively fixed distance from each other. The central section of therod member is designed to engage a section of a tissue-engineered matriximplant. In a preferred embodiment, the implantation members have aseries of ridges extending out from the outer surfaces of theimplantation members to assist in preventing withdrawal from a bone siteor other anchoring site after the implantation members are implantedinto previously-created bore holes.

[0012] Yet another aspect of the present invention is a method of usingthe graft fixation device of the present invention to affix a matrixcontaining tissue-engineered tissue to a bone.

[0013] Still yet another aspect of the present invention is a graftfixation device combination which is the combination of a fixationdevice and an insertion device. The fixation device has a firstimplantation member. The implantation member has a longitudinal axis, aproximal end, a distal end, an outer surface, and a longitudinal passagetherethrough. The fixation device also has a second implantation member.The second implantation member has a longitudinal axis, a proximal end,a distal end, an outer surface, and a longitudinal passage therethrough.Each implantation member has a proximal annular face on its proximal endsurrounding the longitudinal passages. There is a connecting memberconnecting the first and second implantation members. The connectingmember has a central section, a first end extending from the firstimplantation member and a second end extending from the secondimplantation member. There are a pair of insertion devices. Eachinsertion device is a member having a proximal end, a distal tapered endand a longitudinal passage therethrough. The distal end of eachimplantation member is in engagement with the proximal end of aninsertion device. Optionally an insertion device is mounted to thedistal end of an implantation member.

[0014] Yet another aspect of the present invention is a graft fixationdevice. The graft fixation device has first and second implantationmembers. The members are elongated and preferably have a cylindricalconfiguration. The members also have distal ends, proximal ends, andlongitudinal axes. There are longitudinal passages extending through theentire length of each implantation member. The members have outersurfaces. The implantation members are connected to each other by a rodmember having first and second ends and a central section. The first endof the rod member extends from the proximal end of the firstimplantation member and the second end of the rod member extends fromthe proximal end of the second implantation member. The rod member ispreferably relatively rigid and may be configured to have a variety ofgeometric shapes, for example, an inverted “0” shape. However, the rodmember may also be flexible. The rod member maintains the b The wingmember facilitates such engagement. In a preferred embodiment, theimplantation members have a series of ridges extending out from theouter surfaces of the implantation members to assist in preventingwithdrawal from a bone site or other anchoring site after theimplantation members are implanted into previously-created bore holes.

[0015] Yet another aspect of the present invention is a method of usingthe above-described graft fixation device having a laterally extendingwing member to affix a matrix containing tissue-engineered tissue to abone.

[0016] A further aspect of the present invention is a graft fixationdevice combination which is the combination of a fixation device and aninsertion device. The fixation device has a first implantation member.The implantation member has a longitudinal axis, a proximal end, adistal end, an outer surface, and a longitudinal passage therethrough.The fixation device also has a second implantation member. The secondimplantation member has a longitudinal axis, a proximal end, a distalend, an outer surface, and a longitudinal passage therethrough. Eachimplantation member has a proximal annular face on its proximal endsurrounding the longitudinal passages. There is a connecting rod memberconnecting the first and second implantation members. The connecting rodmember has a central section, a first end extending from the firstimplantation member and a second end extending from the secondimplantation member. Extending laterally outward from the connectingmember is at least one wing member. There are a pair of insertiondevices. Each insertion device is a member having a proximal end, adistal tapered end and a longitudinal passage therethrough. The distalend of each implantation member is in engagement with the proximal endof an insertion device. Optionally an insertion device is mounted to thedistal end of an implantation member.

[0017] Yet another aspect of the present invention is a method of usingthe above-described graft fixation device combination having a laterallyextending wing member to affix a matrix containing tissue-engineeredtissue to a bone.

[0018] A further aspect of the present invention is a graft fixationdevice. The graft fixation device has a first implantation member and asecond implantation member. Each implantation member has an outersurface, a longitudinal axis, a proximal end and a distal end. Extendingfrom, or mounted to, the distal end of each implantation member is apenetrating insertion member. The implantation members have alongitudinal passage, and proximal and distal openings in communicationwith the passage. The insertion members have outer surfaces, proximalends, distal ends, and longitudinal axes. Each insertion member has alongitudinal passage and a proximal opening. The longitudinal passagehas a distal closed, blind end. The proximal opening of each insertionmember is in communication with the distal opening of the implantationmember and the longitudinal passage of the insertion member. Theimplantation members are connected to each other by a retention memberhaving first and second ends and a central section. The first end of theretention member extends from the proximal end of the first implantationmember and the second end of the retention member extends from theproximal end of the second implantation member. The retention member ispreferably relatively rigid, and may be configured to have a variety ofgeometric shapes, for example, an inverted “U” shape. However, theretention member may also be flexible. Optionally, extending laterallyoutward from the retention member is at least one wing member. Thecentral section of the retention member with the optional wing membermay engage a section of an implant such as a tissue-engineered matriximplant.

[0019] Yet another aspect of the present invention is a method of usingthe above-described graft fixation device to affix a matrix to a bone,e.g., to mount a matrix to a bone.

[0020] Still yet a further aspect of the present invention is a novelinstrument which can be used in a surgical procedure to insert theabove-described graft fixation device in bone.

[0021] These and other features and advantages of the present inventionwill become more apparent from the following description andaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0022]FIG. 1 is a perspective view of a graft fixation device of thepresent invention.

[0023]FIG. 2 is a cross-sectional view of the graft fixation device ofFIG. 1 taken along view line 2-2.

[0024] FIGS. 3-6 illustrate a surgical procedure for affixing a matrixto bone using the graft fixation device of the present invention.

[0025]FIG. 7 is an illustration of a graft fixation device of thepresent invention after the implantation members have been implanted inbore holes in bone illustrating the device affixing a matrix securely tothe surface of a bone.

[0026]FIG. 8 is a cross-sectional view of the graft fixation device ofFIG. 7 implanted in bone, and taken along View Line 8-8.

[0027]FIG. 9 is an alternative embodiment of a graft fixation device ofthe present invention having two connecting members.

[0028]FIG. 10 is a perspective view of an instrument useful for makingbore holes in bone into which the implantable members of the graftfixation devices of the present invention may be emplaced.

[0029]FIG. 11 is a perspective view of an instrument useful forimplanting the device of the present invention into bore holes made inbone.

[0030]FIG. 12 is a view of a tissue engineered matrix secured to a bonewith several graft fixation devices of the present invention.

[0031]FIG. 13 is a perspective view of an alternate embodiment of agraft fixation device of the present invention.

[0032]FIG. 14 is a side view of the graft fixation device of FIG. 13.

[0033]FIG. 15 is an end view of the graft fixation device of FIG. 14.

[0034]FIG. 16 is a cross-sectional view of the graft fixation device ofFIG. 14, taken along View-Line 16-16.

[0035]FIG. 17 is a cross-sectional view of the tissue retention memberof the graft fixation device of FIG. 14, taken along View-Line 17-17.

[0036]FIG. 18 is a perspective view of an insertion member useful toinsert a graft fixation member of the present invention.

[0037]FIG. 19 is an exploded perspective view of an insertioninstrument, a graft fixation device, and two insertion members.

[0038]FIG. 20 is a side view of the distal end of the insertioninstrument, a graft fixation device, and insertion members engaged inbone, prior to removal of the insertion device.

[0039]FIG. 21 is a cross-sectional view taken along View-Line 21-21 ofFIG. 20 of the prong of the insertion instrument, and a section of theretention member engaged in a longitudinal groove of the prong.

[0040]FIG. 22 is an exploded perspective view of the distal end of aninsertion instrument of the present invention, illustrating a removabledistal end assembly for creating bore holes in bone for receiving thefixation devices of the present invention, wherein the assembly has anend member and pins.

[0041]FIG. 23 is a cross-section of the assembly end member of FIG. 22,taken along View-Line 23.

[0042]FIG. 24 is a perspective view of the assembly end of FIG. 22,completely assembled and ready for use.

[0043]FIG. 25 is a cross-sectional view of the end assembly of FIG. 24,taken along View-Line 25-25.

[0044]FIG. 26 is an exploded perspective view of an insertion instrumentof the present invention having a removable distal end assembly usefulfor inserting the graft retention members of the present invention intobore holes in a bone, having an end assembly member and two pins; whenused with insertion members, the instrument can be used to emplace thefixation devices directly into bone without first forming bone boreholes.

[0045]FIG. 27 is a cross-sectional view of the end assembly member ofFIG. 26.

[0046]FIG. 28 is a perspective view of the distal end of the insertioninstrument of FIG. 26, having the end assembly member and prongs fullyassembled and mounted.

[0047]FIG. 29 is a cross-sectional view of the distal end of theinsertion instrument of FIG. 28 take along View-Line 29-29.

[0048]FIG. 30 is a cross-sectional view of the instrument of FIG. 29taken along View-Line 30-30.

[0049]FIG. 31 illustrates a fixation device of the present member havingan insertion member molded into the distal end of each implantationmember.

[0050]FIG. 32 is a cross-sectional view of the fixation device of FIG.31.

[0051]FIG. 33 is a perspective view of an alternate embodiment of agraft fixation device of the present invention having laterallyextending wing members.

[0052]FIG. 34 is a view of a matrix secured to a bone with several graftfixation members of FIG. 33.

[0053]FIG. 35 is a perspective view of yet another alternate embodimentof a graft fixation device of the present invention having laterallyextending wing members.

[0054]FIG. 36 is a view of a matrix secured to a bone with several graftfixation members of FIG. 35.

[0055]FIG. 37 is a perspective view of an alternate embodiment of agraft fixation device of the present invention; the implantation memberhas a longitudinal passage that extends partially therethrough.

[0056]FIG. 38 is a cross-sectional view of the graft fixation device ofFIG. 37 taken along View-Line 38-38, also illustrating the mountingprongs of the insertion instrument.

[0057]FIG. 39 is a top view of a matrix secured to a bone with severalof the graft fixation members of FIG. 37.

[0058]FIG. 40 is a cross-sectional view of the retention member of thefastener of FIG. 37 taken along View-Line 40-40.

[0059]FIG. 41 is a cross-sectional view of the retention member of thefastener of FIG. 37 taken along View-Line 41-41.

[0060]FIG. 42 is an exploded perspective view of an insertion instrumentuseful to apply the fasteners of FIG. 37.

[0061]FIG. 42A is a partial magnified perspective view of the distal endof the shaft of the instrument of FIG. 42 illustrating the mountingprongs.

[0062]FIG. 43 is a perspective view of the instrument of FIG. 43 mountedto a slap hammer.

[0063]FIG. 44 is a cross-sectional view of the instrument of FIG. 43taken along View Line 44-44.

[0064]FIG. 45 is a cross-sectional view of the instrument of FIG. 44taken along View Line 45-45.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0065] The graft fixation devices of the present invention can be madefrom conventional bio-compatible materials, including absorbable andnon-absorbable materials, as well as biodegradable materials. Thenon-absorbable materials which can be utilized include conventionalbiocompatible materials such as stainless steel, polyethylene, Teflon,Nitinol, non-absorbable polymers, other bio-compatible metals, ceramics,combinations thereof and the like. The absorbable materials which can beused to manufacture the graft fixation devices of the present inventionwill typically include those conventional bioabsorbable or bioresorbablematerials known in this art which can be effectively molded or machined.The bio-absorbable and bio-resorbable materials include polylactic acid,polydioxanone, polycaprolactone, polyglycolic acid, polygalactic acid,other known biocompatible bioabsorbable and bioresorbable polymers,ceramics, composites, combinations thereof and the like and equivalentsthereof.

[0066] Referring now to FIGS. 1-2, a preferred embodiment of a graftfixation device 10 of the present invention is illustrated. The graftfixation device 10 is seen to have implantation members 20. Theimplantation members 20 are seen to be elongated members, preferablyhaving a substantially cylindrical shape. The members 20 may have othergeometric shapes including conical, pyramidal, polygonal, cubic,spherical, etc. The implantation members 20 are seen to have distal ends22 and proximal ends 24. Each implantation member 20 is seen to have anouter surface 28 and a longitudinal axis 29. Each member 20 is also seento have longitudinal passage 35 extending therethrough. The implantationmembers 20 are also seen to have optional frustoconical ends 30, andproximal endface surfaces 32. Although it is preferred that endfacesurfaces 32 be flat, endface surface 32 may also be angled, concave,convex, etc. Endface surface 32 is seen to have central circular opening36 in communication with passage 35. Preferably, central opening 36 willhave a circular cross-section, but it may have other geometriccross-sections as well including elliptical, polygonal, square,rectangular, combinations thereof and the like. Members 20 are also seento have distal end face surfaces 37 having circular openings 38 incommunication with passages 35. As shown with the optional frustoconicalend 30, the annular end face surface 37 is of de minimis thicknessaround opening 38, however this thickness would increase in the absenceof a frustoconical end. Also seen to extend out from the surface 28 ofmember 20 are a series of optional projections 40 having tissueengagement edges 44. Without the projections 40, the surface 28 of themember 20 will be smooth.

[0067] The device 10 is seen to have graft retention member 50connecting the implantation members 20. Retention member 50 is seen tobe a rod-like member having first end 52, second end 54 and centralsection 55. First end 52 is seen to extend from proximal endface surface32 of the first member 20 while end 54 is seen to extend up from theproximal endface surface 32 of the other member 20. The ends 54 and 52of retention member 50 may also if desired extend from or be mounted toany section of outer surface 28. The connecting member 50 is seen to bepreferably bent or shaped into three segments including top segment 55and leg segments 56. The top segment 55 is seen to be substantiallyperpendicular to the leg segments 56. Although it is preferred thatconnecting member 50 have an inverted “U” configuration, the connectingmember 50 may have other geometric configurations includingsemicircular, arced, curved, triangular, polygonal, U-shaped, and thelike and combinations thereof. The ends 52 and 54 of connecting member50 may be permanently affixed to the implantation members 20, or may beremovably attached thereto in a conventional manner. Member 50 may berigid or flexible. Member 50 will have a sufficient surface area toeffectively retain a tissue-engineered matrix in place on a bone orother body surface. Preferably, connecting member 50 will have acircular cross-section, but may have other geometric cross-sections aswell including elliptical, polygonal, square, rectangular, combinationsthereof and the like. Member 50 may be rigid or flexible, and may have asingle filamentary structure or have multiple interconnected filamentsor members.

[0068] Referring now to FIGS. 3-8, the use of the graft fixation devices10 of the present invention in a surgical procedure is illustrated.Referring first to FIG. 3, the initial step, prior to the installationof a matrix containing a tissue-engineered tissue using a graft fixationdevice 10 of the present invention, is to drill or “tap” two bore holes200 into a bone 210, for example, subchondral bone in the knee joint.The bore holes 200 are seen to be cylindrical holes having a bottom 208and an open top 202 and side walls 205. Optionally, the bore holes maybe bone tunnels with a continuous passage and no bottom, or an openbottom. It is particularly preferred to tap the holes in the bone byusing an instrument 400 as illustrated in FIG. 10 which has a proximalsection conventionally referred to in this art as a “slap hammer”section. The term “tapping” or “tap” as used herein is defined to mean aprocedure wherein the distal pointed prongs 420 extending from thedistal end 415 of the shaft 405 of instrument 400 are located over abone site, and the proximal end 410 of instrument 400 is tapped or hitwith slidable hammer handle 450 (of the “slap hammer”), which slides onshaft 460 between proximal end 410 and proximal stop 470, to form thebone bore holes 200. The distal end 465 of shaft 460 is connected toproximal end 411. Proximal stop 470 is mounted to proximal end 467.Hammer handle 450 is seen to have grasping section 451, collars 455 andlongitudinal passage 457. Those skilled in the art will appreciate thata similar pointed instrument may be used to “tap” in the bore holes intobone, that is, any instrument having a nail-like distal end. Inaddition, although not preferred, one bone bore hole at a time may be“tapped” in. If the surgeon decides to drill the bore holes into bone,any conventional surgical drilling apparatus may be used. After the boreholes 200 are formed into the bone 210, the matrix 220 containingtissue-engineering tissue is placed upon the bone surface 201 by thesurgeon as seen in FIG. 4. Next, the graft fixation device 10 is mountedon to the insertion instrument 250. Insertion instrument 250, asillustrated in FIG. 11, is seen to be an elongated rod 260 having aproximal end 262 and a distal end 264. Mounted to the distal end 264 ofthe rod 260 is the depth stop 290. The depth stop 290 is seen to be asubstantially rectangular member which is mounted perpendicular to thelongitudinal axis 251 of the rod 260. Depth stop 290 is seen to havebottom 292. Extending distally from the bottom 292 of plate member 290is a pair of parallel, spaced-apart, mounting prongs 270. The mountingprongs 270 are seen to be substantially rod-like members having distalpointed tips 277 and proximal ends 272. The prongs 270 are seen to havefirst section 273 and distal section 275. Section 273 is seen to have agreater cross-sectional dimension than distal section 275 such that theentire section 275 is insertable into passages 35 of members 20, whileproximal section 273 is not insertable therein. Instrument 250 is alsoseen to have a “slap hammer section” consisting of proximal shaft 300extending from proximal end 262, slidable hammer handle 320 (the “slaphammer”) which is slidable upon shaft 300 between proximal end 262, andproximal stop 330. Hammer handle member 320 is seen to have graspingsection 325, end collars 327 and longitudinal passage 329. The graftfixation device 10 is mounted to the insertion instrument 250 by slidingthe implantation members 20 onto the prongs 270 such that the distalsections 275 of members 270 are engaged within the longitudinal passages35 of members 20 and distal points 277 protrude beyond the end of distalendface surfaces 37. Then, as seen in FIGS. 5 and 6, the instrument 250is manipulated such that the graft fixation device 10 is insertedthrough matrix 220 and into bone 210 by moving the implantation members20 mounted on prongs 270 into the bore holes 200 such that the members20 are engaged in the bore holes 200, and such that the tissueengagement section 55 of the retention member 50 engages the matrix 220such that the matrix 220 is firmly engaged against the surface 201 ofthe bone 210. If desired, holes may be cut into matrix 220 prior toinsertion of device 10. Then, as seen in FIG. 7, the insertioninstrument 250 is withdrawn proximally causing the prongs 270 to bewithdrawn from the passages 35 of the implantation members 20, therebyleaving the graft fixation device 10 engaged in the bone bore holes, andcausing the matrix 220 to be maintained in engagement with the surface201 of bone 210. The “slap hammer” section of instrument 250 may assistin removal of the prongs. A cross-sectional view illustrating the device10 engaged in bone 210 while maintaining the matrix 220 on bone surface201 is seen in FIG. 8.

[0069]FIG. 12 illustrates a matrix 220 mounted to bone surface 201 ofbone 210 having multiple fixation devices of the present inventioninstalled to secure the matrix 220. The number, anatomical location andorientation of fixation devices 10 necessary to provide sufficientlyeffective fixation will vary with the size and type of implant ormatrix, the type of tissue, the age of the patient, the size of thepatient's defect, the size of the fixation devices, the material ofconstruction of the fixation devices, the load on the tissue at therepair site, etc.

[0070] Those skilled in the art will appreciate that the size of thefixation devices of the present invention will vary in accordance with anumber of variables including the specific design of the device, thematerials of construction, the specific application for the devices, thetype of surgical procedure, etc. Similarly, the size of the matricesfixated with these devices will similarly vary. The Figures which arepart of this specification are merely schematic and illustrative of thedevice and method of the present invention; the actual dimensions of thedevices and matrices may vary in practice.

[0071] The following example is illustrative of the principles andpractice of the present invention although not limited thereto.

EXAMPLE

[0072] Six sheep were prepared for a surgical procedure using standardaseptic surgical techniques including the use of fully sterilizedinstruments and equipment, and conventional anesthesia procedures andprotocols. The surgeon then created 7 mm diameter chondral (fullthickness cartilage) defects on a weight-bearing area of the medialfemoral condyle and in the trochlear groove in the right stifle (knee)in each of the six skeletally mature sheep. Defects were created using aspecialized drill with a depth-stop to prevent subchondral bone exposureor penetration. The base surfaces of all the defects were thenmicrofractured with a specialized micropick tool to provide access forcellular migration. The subjects were then separated into three groupsof two subjects each:

[0073] Group 1: defect filled with a collagen matrix, fixed with thegraft fixation device of the present invention.

[0074] Group 2: defect filled with a collagen matrix, fixed with 9-0absorbable Vicryl™ sutu re (interrupted stitch technique, approximately12 strands per matrix).

[0075] Group 3: unfilled defect (control group).

[0076] Both defects in a given stifle received the same treatment orserved as controls.

[0077] For the two sheep in Group 1, after a defect had been created andmicrofractured, a punch tool 400 was used to create the two requisitebore holes in the subchondral bone to receive one graft fixation deviceof the present invention. Only one polydioxanone device (4 mm tip-to-tipdistance) was used to attach each matrix. To create the bore holes, thepunch tool was centered in the defect, oriented in the sagittal plane,and hit or “tapped” with a slap hammer repeatedly until it penetratedseveral millimeters into the subchondral bone. Next, a 7 mm diametercircular collagen matrix, saturated with saline, was placed in thedefect and then blotted dry to remove excess saline. When the insertertool 250 was loaded with the graft fixation device 10 of the presentinvention, the device and inserter tool were centered above the matrixand oriented in the sagittal plane. The surgeon then located thepreviously created bore holes by slowly advancing the distal tips of theinserter through the matrix. Once the surgeon located the holes with theinserter tips, a hammer was used to fully advance the inserter tool (andimplantation members 20 of the fixation device 10) through the matrixand into the subchondral bone. The inserter tool had a depth stop toprevent the implantation members 20 from being inserted too deeply,thereby assuring the proper placement of the implantation membersthrough the matrix. The insertion was completed when the connectingretention member between the two implantation members initially startedto compress the collagen matrix, thereby indicating secure fixation withthe underlying subchondral bone. After the two defects in a given stiflehad each been repaired with a matrix and fixation device, the stifle wasclosed and the sheep was allowed to recover. It was noted by the surgeonthat it took approximately one minute to attach a matrix with a fixationdevice of the present invention (Group 1), versus approximately 15minutes to attach a matrix with suture alone and the requisite suturemanipulation and knot tying (Group 2).

[0078] Two weeks after the surgeries were completed, the knee jointswere surgically opened for examination. Gross macroscopic assessment ofthe joints demonstrated that all four matrices held by the graftfixation device of the present invention were fully intact. However, allfour matrices held by sutures alone were only partially intact with, onaverage, approximately 30% of the sutures broken on any given matrix.

[0079] Another embodiment of the fixation device of the presentinvention having multiple retention members is seen in FIG. 9. Thedevice 300 is seen to have a pair of implantation members 310. Theimplantation members 310 are substantially cylindrical members havinglongitudinal axis 311, distal ends 314 and proximal ends 312. Eachimplantation member 310 is seen to have a longitudinal passage 320. Themembers 310 are seen to have a distal frustoconical end 330, outersurface 350, and ridges 355 extending outward from surface 350. Themembers 310 are seen to be connected by a pair of retention members 340,having first and second ends 342 and 344 respectively.

[0080] Yet another embodiment of a fixation device of the presentinvention is illustrated in FIGS. 13-17. The graft fixation device 500is seen to have implantation members 520. The implantation members 520are seen to be elongated members, preferably having a substantiallycylindrical shape. The members 520 may have other geometric shapesincluding conical, pyramidal, polygonal, cubic, spherical, etc. Theimplantation members 520 are seen to have distal ends 522 and proximalends 524. Each implantation member 520 is seen to have an outer surface528 and a longitudinal axis 529. Each member 520 is also seen to havelongitudinal passage 535 extending therethrough. The implantationmembers 520 are also seen to have optional frustoconical ends 530, andproximal end face surfaces 532. Although it is preferred that endfacesurfaces 532 be flat, endface surfaces 532 may also be angled, concave,convex, etc. Each endface surface 532 is seen to have central circularopening 536 in communication with passage 535. Preferably, centralopening 536 will have a circular cross-section, but it may have othergeometric cross-sections as well including elliptical, polygonal,square, rectangular, combinations thereof and the like. Members 520 arealso seen to have distal end face surfaces 537 having circular openings538 in communication with passages 535. Preferably, endface surfaces 537have a sharp edge configuration, but may also have various widths with arounded or flat configuration. As shown with the optional frustoconicalend 530, the annular end face surface 537 is of de minimis thicknessaround opening 538, however this thickness would typically increase inthe absence of a frustoconical end.- However, although not preferred,even with a frustoconical, the end surface 537 could have various widthsas previously mentioned. Also seen to extend out from the surface 528 ofmember 520 are a series of optional projections 540 having tissueengagement edges 544. Without the projections 540, the surface 528 ofthe member 520 will be smooth, however, it will be appreciated thatsurface 528 could be rough, or could have a variety of conventionalprojections such as cones, hemispheres, rods, hooks, etc., and the likeand equivalents thereof.

[0081] The device 500 is seen to have graft retention member 550connecting the implantation members 520. Retention member 550 is seen tobe a band-like member preferably having an oval cross-section. Theretention member 550 is seen to have first end 552, second end 554 andcentral section 555. First end 552 is seen to extend up from proximalendface surface 532 of the first member 520 while end 554 is seen toextend up from the proximal endface surface 532 of the other member 520.A section 557 of end 552 is seen to extend out from section 539 ofsurface 528, while section 558 of second end 554 is also seen to extendout from a section 539 of surface 528. The ends 554 and 552 of retentionmember 550 may if desired extend from or be mounted to any section ofouter surface 528. The connecting member 550 is seen to be preferablybent or shaped into three segments including top segment 555 and legsegments 556. The top segment 555 is seen to an arc shaped member, andthe leg segments 56 are seen to be preferably perpendicular to surfaces532. Although it is preferred that connecting member 550 have aninverted “U” configuration, the connecting member 50 may have othergeometric configurations including semicircular, arced, curved,triangular, polygonal, V-shaped, and the like and combinations thereof.The ends 552 and 554 of connecting member 550 may be permanently affixedto the implantation members 520, or may be removably attached thereto ina variety of conventional manners, for example, a ball and socket joint,a plug joint, etc. Member 550 may be rigid or flexible. Member 550 willhave a sufficient surface area to effectively retain a tissue-engineeredmatrix in place on a bone or other body surface. Preferably, connectingmember 550 will have an oval cross-section, but may have other geometriccross-sections as well including circular, elliptical, polygonal,square, rectangular, combinations thereof and the like. Member 550 maybe rigid or flexible, and may have a single filamentary structure orhave multiple interconnected filaments or members.

[0082] An embodiment of graft fixation device 500 having lateral wingmembers 580 is seen in FIGS. 35 and 36. Referring to FIG. 35, the device500 is seen to have wing members 580 extending laterally from thecentral section 555 of the connecting member (or graft retention member)550. The wing members 580 are preferably elongated members having adistal end 584 and a proximal end 582. Extending from the distal end 584is a rounded nose section 590. If desired nose section 590 may haveother geometric configurations including conical, pyramidal, and thelike, etc. The wing members 580 are seen to have outer surface 586. Asseen in FIG. 35, the wing members 580 are seen to have a circularcross-section, tapering from a maximum dimension at proximal end 582.There is seen to be a transition section 592 between the proximal end582 and the top 555 of retention member 550. If desired, the diametermay be constant along the length of the wing member 580. The wingmembers 580 may have other cross-sectional configurations as wellincluding oval, square, rectangular, triangular, polygonal, curved,combinations thereof and the like. The length of the wing members 580 issufficient to provide effective retention of an implant graft. Ifdesired, although not preferred, the wing members 580 may short or ofmedium length, rather than elongated. Similarly, the width or diameterof the wing members will vary to provide sufficiently effective graftretention. Although it is preferred to have two opposed wing members 580extending laterally from the retention member 550, a single wing member580 may be used, or a plurality of wing members 580 may be used withdevice 500. The retention devices 500 having wing members 580 areillustrated implanted in bone and securing a graft matrix implant inFIG. 36. The method of implanting a device having wing members 580 issubstantially similar, and having the same steps, to implanting a device500 without wing members 580 as described and illustrated previouslyherein. As seen in FIG. 36, at least a portion of surface 586 engagesthe top of the matrix 220 on bone 210.

[0083] Another aspect of the present invention is a distal insertionmember (device) useful with the fixation devices of the presentinvention. As seen in FIG. 18, the insertion device 600 is seen to be asubstantially cylindrical member having proximal end 610 and distal end620. Proximal end 610 is seen to have a flat end surface 612.Frustoconical end section 630 is seen to extend distally from distal end620, although device 600 may have other configurations as well. Ifdesired, distal end 620 can have any tapered or curved configuration,but it is preferred that it have a frustoconical end section extendingtherefrom. The frustoconical end section 630 is seen to have outersurface 632 and distal tip 640. The member 600 is also seen to haveexterior surface 650. Extending through member 600 is the longitudinalpassage 660 having first circular opening 665 in communicationtherewith, and second circular opening 667 in tip 640 in communicationtherewith. The insertion members 600 are used in combination with thefixation members of the present invention to engage the fixation memberin bone simultaneously with tapping the bore holes into bone, therebyeliminating the need for a separate step to form the bore holes prior toinserting the fixation member.

[0084] Referring to FIGS. 19-21, the previously mentioned combination ofan insertion member 600 and a fixation member 500 is illustrated.Initially, a fixation member 500 is mounted to prongs 700 extending fromthe distal end 415 of the shaft 405 of instrument 400. Each prong 700 isseen to have first cylindrical section 710 extending from the distal end415 of the shaft 405. Each cylindrical section 710 is seen to haveproximal end 711 and distal end 712, and receiving grooves 715.Extending from the distal end 712 of each first section 710 is thecentral pin section 720. Central pin section 720 is seen to haveproximal end 722 and distal end 724. Extending distally from distal end724 of central pin section 720 is the distal pin member 730. Distal pinmember 730 is seen to have proximal end 732 and distal pointed end 734.

[0085] If desired, the insertion member 600 may be molded into oraffixed to the distal end of an implantation member 520, thereby forminga unitary structure as seen in FIG. 31 and FIG. 32. In addition, theinsertion member 600 may be mounted to the distal end of an implantationmember 520 in a conventional manner by gluing, cementing, mechanicalfastening, friction fit and the like and equivalents thereof.

[0086] The combination of a unitary implantation device 500 having wingmembers 580 as previously described and an insertion member 600 isillustrated in FIGS. 33 and 34. This combination with wing members 580securing a matrix 220 to bone 210 is seen in FIG. 34. If desired,although not shown, the insertion members 600 may be separate from theinsertion device 500 having wing members 580. The method of insertingthis combination having wing members 580 is substantially identical tothat described and illustrated herein.

[0087] The combination of the insertion members 600 and fixationmembers, such as fixation member 500 of the present invention, are usedto affix a matrix to bone in the following manner. Initially, theimplantation members 520 of a fixation device 500 are placed upon prongs700 of an instrument 400 such that the leg members 556 are at leastpartially engaged in grooves 715 in first section 710 (see FIG. 21),and, intermediate sections 720 of pin members 700 are engaged inpassages 535 of implantation members 520, while pin members 730 extendout from the distal ends of the implantation members 520. Then,insertion members 600 are placed over the pin members 730, such that thepin members 730 are engaged in passages 660, and such that the pointedpiercing ends 734 extend beyond the distal ends 640 of the insertionmember 660. Then, the tool 400 and the assembly consisting of fixationdevice 500 and insertion member 600 is placed over a tissue matrix 220placed upon a bone 210. The piercing points are then pressed throughmatrix 220 to contact the surface 211 of bone 210. A slap-hammer sectionof instrument 400 is engaged to drive the piercing points 734, insertionmembers 600 and implantation members 520 into the bone 210 as bore holes200 are formed in the bone. The instrument 400 is then withdrawnproximately, thereby removing the intermediate sections 720 of prongs700 from the implantation members 520 and the pin members 730 from theinsertion members 600, leaving the insertion members 600 and theimplantation members 520 securely in the bone (as seen in FIG. 20). Thiscompletes the affixation of the matrix 220 to the bone 210 using asingle step, wherein the bore holes in the bone are formedsimultaneously as insertion members 600 and fixation device 500 areemplaced in the bone.

[0088] It is particularly preferred to use conventional remotevisualization surgical procedures when inserting the fixation devices ofthe present invention. For example, inserting a scope through a trocarcannula into the joint or body cavity, while insufflating the joint orbody cavity.

[0089] The insertion members 600 will typically be made from a strong,hard, bioabsorbable material such that they can be driven into bonewithout fracturing or breaking. Examples of the types of materials whichcan be used to make the insertion member 600 include polylactic acid,polyglycolic acid, tricalcium phosphate, calcium phosphate, tetracalciumphosphate and hydroxyapatite, and any copolymers, mixtures or blendsthereof. Although not preferred, it is possible to make the insertionmembers from a conventional biocompatible material which is notbioabsorbable or biodegradable, such as titanium, stainless steel,ceramics, Nitinol and the like and equivalents thereof. The insertionmember 600 assists in forming the bore holes 200 while protecting theimplantation members 520.

[0090] FIGS. 22-23 illustrate a disposable distal end assembly 800 foran instrument 400 of the present invention. When using the disposableassembly 800, it is preferable that the distal end 415 of the shaft 405of instrument 400 have screw threads 418, although other conventionaldetachable mounts may be used, for example a bayonet-type mount, lockinglevers and tabs, male and female mating sections, etc. As seen in FIGS.22-25, the assembly 800 consists of housing 810 having proximal end 811and distal end 817. Housing 810 is seen to have hollow cavity 815therein. Cavity 815 is seen to be in communication with proximal endopening 812 and distal end openings 820. Member 810 is seen to haveouter surface 822. Outer surface 822 is preferably knurled to facilitatethe grasping and turning of the housing 810. Housing 810 is further seento have distal end surface 825. The outer surface 822 is seen to have atapered section 823 that tapers toward end face 825. Contained withincavity 815, on inner surface 818 are the screw threads 819. Assembly 800is also seen to have driving pin members 830. Each driving pin member830 is seen to have proximal disk member 832 mounted to proximal end831, shaft section 834 and distal pointed end 838. Surrounding eachopening 820 on the interior of the member 810 are the annular recesses840. The assembly 800 is mounted to the distal end 415 of the instrument400 in the following manner. The pins 830 are inserted into cavity 815and through openings 820 such that the shafts 834 and distal piercingpoints 838 extend through end face 825, and the disk members 832 arecontained within the annular recesses 840. Then, the housing 810 ismounted upon the threads of distal end 415 such that threads 418 engagemating threads 819, and screwed further such that the proximal endsurfaces 833 of the disk members 832 are in contact with the distal endface 416 of distal end 415. After use in a surgical procedure, theassembly 800 is removed and discarded. A new sterile assembly 800 isutilized with a cleaned and sterilized instrument 400 for each newprocedure.

[0091] Referring now to FIGS. 26-30, a disposable end assembly 900 formounting to an insertion instrument 250 is illustrated. The insertionmember 250 is seen to have distal end 264, having endface 265 and screwthreads 266. The assembly 900 is seen to have housing 950. Housing 950has proximal end 952 and distal end 956 and exterior surface 954.Extending from distal end 956 is the plate member 960. Plate member 960is seen to have distal surface 962. The exterior surface 954 is seen tohave optional knurling and distal tapered section 957 tapering intoplate member 960. Housing 950 is seen to have internal cavity 955.Housing 950 is also seen to have proximal opening 951 in communicationwith cavity 955 and distal openings 970 also in communication therewith.Housing 950 is seen to have internal screw threads 959 extending frominternal surface 958. Also contained within the interior of housing 950in the distal end 956 is the recessed groove 980. Assembly 900 ismounted to the distal end 264 of instrument 250 in the following manner.Pins 910 are inserted through cavity 950 and openings 970 such thatproximal members 922 are engaged in groove 980. Sections 920 and 930 ofpins 910 extend through openings 970. Sections 920 are seen to havegrooves 925. Then, the housing 950 is screwed on to distal end 264 suchthat the threads 266 engage the mating internal threads 959 of housing950. The housing is tightened until the distal end surface 265 of thedistal end 264 engages the top surfaces 923 of members 922. After asurgical procedure, the assembly 900 is removed from instrument 250 anddiscarded. A new sterile assembly 900 is utilized with a cleaned andsterilized instrument 250 for each new procedure.

[0092] Another alternate embodiment of the graft fixation members of thepresent invention is illustrated in FIGS. 37-41. An embodiment of agraft fixation device 1000 having optional lateral wing members 1080 isseen. Referring to FIGS. 37 and 38, the device 1000 is seen to have wingmembers 1080 extending laterally from the central section 1055 of theconnecting member (or graft retention member) 1050. Retention member1050 is seen to be a band-like member preferably having an ovalcross-section (See FIGS. 40 and 41). The retention member 1050 is seento have first end section 1052, second end section 1054 and centralsection 1055. First end 1052 is seen to extend up from proximal endfacesurface 1112 of the first member 1100 while end 1054 is seen to extendup from the proximal endface surface 1112 of the other member 1100. Asection 1057 of end 1052 is seen to extend out from a section of outersurface 1114, while a section 1058 of second end 1054 is also seen toextend out from a section of outer surface 1114. The ends 1054 and 1052of retention member 1050 may if desired extend from or be mounted to anysection of outer surface 1114, or extend solely from proximal endsurfaces 1112. The connecting or retention member 1050 is seen to bepreferably bent or shaped into three segments including top segment orcentral section 1055 and leg segments or end sections 1056. Although itis preferred that connecting member 1050 have an inverted “U”configuration, the connecting member 1050 may have other geometricconfigurations including semicircular, arced, curved, triangular,polygonal, V-shaped, and the like and combinations thereof. The ends1052 and 1054 of connecting member 1050 may be permanently affixed tothe implantation members 1110, or may be removably attached thereto in avariety of conventional manners, for example, a ball and socket joint, aplug joint, etc. Member 1050 may be rigid or flexible. Member 1050 willhave a sufficient surface area to effectively retain a tissue-engineeredmatrix in place on a bone or other body surface. Preferably, connectingmember 1050 will have an oval cross-section, but may have othergeometric cross-sections as well including circular, elliptical,polygonal, square, rectangular, combinations thereof and the like.Member 1050 may be rigid or flexible, segmented, or may have a singlefilamentary structure or have multiple interconnected filaments ormembers.

[0093] The optional and preferred wing members 1080 are preferablyelongated members having a distal end 1084 and a proximal end 1082Extending from the distal end 1084 is a rounded nose section 1090. Ifdesired nose section 1090 may have other geometric configurationsincluding conical, pyramidal, and the like, etc. The wing members 1080are seen to have outer surface 1086. The wing members 1080 preferablyhave an elliptical or circular cross-section, tapering from a maximumdimension at proximal end 1082. There is seen to be a transition section1092 between the proximal end 1082 and the central section 1055 ofretention member 1050. If desired, the diameter may be constant alongthe length of the wing member 1080. The wing members 1080 may have othercross-sectional configurations as well including oval, square,rectangular, triangular, polygonal, curved, combinations thereof and thelike. The length of the wing members 1080 is sufficient to provideeffective retention of an implant graft and maintain contact of theimplant against a bone, for example, a bone surface. If desired,although not preferred, the wing members 1080 may be of short or mediumlength, rather than elongated. Similarly, the width or diameter of thewing members will vary to provide sufficiently effective graft or matrixretention and contact of the graft or matrix with the bone. Although itis preferred to have two opposed wing members 1080 extending laterallyfrom the retention member 1050, a single wing member 1080 may be used,or a plurality of wing members 1080 may be used with device 1000.

[0094] The members 1100 are seen to have a top section and a bottomsection. The top section consists of implantation member 1110 and alower section consists of penetrating insertion member 1150. The upperimplantation member 1110 is seen to be a substantially cylindricalmember having a proximal end 1120 and a distal end 1130. Preferably thedistal end has a frustoconical configuration. Extending throughimplantation member section 1110 is the passage 1140. Passage 1140 isseen to be an elongated passage. An opening 1141 in proximal endface1112 of implantation member 1110 is seen to be in communication with thepassage 1140. Distal opening 1145 is also seen to communicate withpassage 1140. The implantation member section 1110 is seen to have outerside surface 1114. Extending radially outward from outer surface 1114 isat least one engagement member 1117 having edge 1118 forming a ridge.

[0095] The penetrating insertion member sections 1150 are seen to haveproximal ends 1160 and distal ends 1170. The distal end 1170 preferablyhas a distal penetrating tip 1175. Tip 1175 may be blunt or sharp. Eachpenetrating insertion section 1150 is seen to be a substantiallyconically shaped member having proximal end face 1165 having opening1191 therein. The insertion member sections 1150 are further seen tohave longitudinal passages 1190 having blind end walls 1195. Passage1190 is seen to be in communication with opening 1191 which in turn isin communication with opening 1145, and accordingly passages 1140 and1190 are in communication with each other. If desired, although notpreferred, passage 1190 can continue through the length of insertionmember 1150, with a constant or smaller or tapering diameter, and blindend wall 1195 could be replaced with a flange having an opening or amember protruding radially inward into passage 1190 to engage the distalend of a mounting pin of an insertion instrument.

[0096] The graft fixation devices 1000 are made in a conventional mannerpreferably from bioabsorbable materials as previously mentioned forother embodiments of the fasteners disclosed herein. It is particularlypreferred to co-mold the implantation member section and the insertionmember section, although other conventional means of affixing theimplantation member and the insertion may be used including mechanicalfastening, welding, adhesives, glues, and the like and combinationsthereof. The penetrating insertion member sections 1150 will typicallybe made from a strong, hard, bioabsorbable material such that they canbe driven into bone without fracturing or breaking. Examples of thetypes of materials which can be used to make the penetrating insertionmembers 1150 include polylactic acid, polyglycolic acid, tricalciumphosphate, calcium phosphate, tetracalcium phosphate and hydroxyapatite,and any copolymers, mixtures or blends thereof and equivalents thereof.Although not preferred, it is possible to make the insertion membersfrom a conventional biocompatible material which is not bioabsorbable orbiodegradable, such as titanium, stainless steel, ceramics, Nitinolnickel-titanium alloy, polysulfone, acetal and the like and equivalentsand combinations thereof. The penetrating insertion members 1150 can bemade from conventional processes, including machining, molding,combinations and equivalents thereof and the like. The penetratinginsertion members 1150 assist in forming the implantation or bore holes200 while protecting the implantation member sections 1110. Theimplantation member sections 1110 can be made from conventionalbio-compatible materials, including absorbable and non-absorbablematerials, as well as biodegradable materials. The non-absorbablematerials which can be utilized include conventional biocompatiblematerials such as stainless steel, polyethylene, Teflon, Nitinol,non-absorbable polymers, other bio-compatible metals, ceramics,combinations thereof and the like. The absorbable materials which can beused to manufacture the implantation members 1110 will typically includethose conventional bioabsorbable or bioresorbable materials known inthis art which can be effectively molded or machined. The bio-absorbableand bio-resorbable materials include polylactic acid, polydioxanone,polycaprolactone, polyglycolic acid, polygalactic acid, other knownbiocompatible bioabsorbable and bioresorbable polymers, ceramics,composites, combinations thereof and the like and equivalents thereof.If desired the implantation members 1110 and the insertion members 1150can be made from the same material.

[0097] The graft fixation devices 1000 having wing members 1080 areillustrated implanted in bone 205 and securing a graft matrix implant220 to the surface 210 of the bone 205 in FIG. 39.

[0098] An instrument 1400 and an instrument assembly 1600 useful forimplanting graft fixation devices 1000 is illustrated in FIGS. 42-45.The instrument 1400 is seen to have shaft 1410 having proximal end 1415and distal end 1418. Extending proximally from proximal end surface 1416of proximal end 1415 is threaded rod connector 1417. The shaft 1410 isseen to have a tapered end section 1430 extending from distal end 1418.Extending laterally (radially) out from shaft 1410 toward proximal end1415 are the guide pins 1420. Extending out distally from tapered end1430 are the mounting pins or mounting members 1450 having proximal ends1452 and distal ends 1457 having distal flat end faces 1458. The sleevemember 1470 is seen to be a tubular member having distal end 1477 andproximal end 1472. The member 1470 has inner or longitudinal passage1480 in communication with distal opening 1485 and proximal opening1482. The member 1470 has outer surface outer surface 1475, and aproximal handle section surface 1476 extending therefrom. The sleevemember 1470 is seen to have a plurality of openings 1490 extendingtherethrough in the distal end 1477 in communication with inner passage1480. The openings 1490 act as windows so that the interior of sleevemember 1470 may be viewed adjacent thereto. The sleeve member 1470 isseen to have opposed longitudinal slots 1492 extending therethrough inthe proximal end 1472. The sleeve member 1470 is concentrically andslidably mounted over shaft 1410 such that the pins 1420 are containedwithin slots 1492, and mounting pins 1450 are contained within passage1480 adjacent to distal end 1477 of sleeve member 1470, or extending outfrom distal end 1477 of sleeve member 1470.

[0099] An assembled insertion instrument assembly 1600 is seen in FIG.43, having the sleeve member 1470 in the maximum proximal position toexpose the mounting members 1450. The insertion instrument assembly 1600is seen to have insertion instrument 1400 with an optional conventionalslap hammer assembly 1530 mounted to the proximal end 1415 of shaft1410. The slap hammer assembly 1530 is seen to have a tapered connectingsection 1540 having distal end 1541 and proximal end 1546. Distal end1541 is seen to have threaded cavity 1542 extending therein, andproximal end 1546 is seen to have threaded cavity 1547 extendingtherein. The slap hammer assembly 1530 is seen to have support rod 1550having proximal end flange 1555 and distal threaded end 1558. Theassembly has handle member 1560 slidably mounted on rod 1550. Handlemember 1560 is seen to have longitudinal passage 1568, proximal flangemember 1562 and distal flange member 1564. The threaded end 1558 ofsupport rod 1550 is engaged in threaded cavity 1547 of taperedconnecting section 1540. The threaded rod connector 1417 of shaft 1410is similarly engaged in threaded cavity 1542 of connecting section 1540.The insertion instrument 1400 may be used without slap hammer assemblyto insert graft fixation devices of the present invention. For example,the proximal end 1415 of shaft 1410 may be connected to otherconventional force transmitting devices, or the proximal end 1415 may behammered directly by the surgeon using a conventional orthopedic hammer.

[0100] A method of implanting a graft fixation device 1000, havingoptional wing members 1080, using an insertion instrument assembly 1600is described as follows. It should be noted that although it ispreferred to insert the graft fixation devices 1000 directly into boneusing the insertion instrument assembly 1600 without pre-drilling orotherwise pre-creating bore holes in bone, the device 1000 can also beutilized to affix a matrix to bone where the bore holes are pre-drilledor otherwise pre-created.

[0101] In using the graft fixation device 1000 of the present inventionhaving optional wing members 1080 with insertion instrument assembly1600, an incision is made in a conventional manner to access thepatient's bone (via a conventional arthroscopic or open procedure) whereit is desired to implant a matrix. After the matrix 220 is positioned onthe surface 210 of bone 205 as seen in FIG. 39, a device 1000 is mountedto the mounting pins 1450 of insertion instrument 1400 of insertionassembly 1600. Next the sleeve member 1470 is moved distally to coverthe insertion device 1000, thereby protecting the device 1000, and thesurgeon locates the device at the surgical site using insertioninstrument assembly 1600. Next, the surgeon slides the sleeve 1470proximally to uncover the insertion device 1000. Then, the distal end ofpenetrating insertion member 1150 is contacted with the top 221 of thematrix 220. The optional slap hammer assembly 1530 is manipulated todrive the penetrating insertion member 1150 and the implantation member1100 into the bone 205. This causes the central section 1055 ofretention member 1050 and the lateral wing member 1080 to engage thematrix 220 and substantially cause the bottom surface 222 of the matrix220 to engage the surface 210 of the bone 205. Multiple fixation devices1000 are inserted in the same manner into the matrix 220 in a spatialconfiguration sufficient to effectively affix or mount the matrix 220 tothe bone 205. During insertion with the insertion instrument assembly1600 having insertion instrument 1400 and slap hammer assembly 1530, thedistal flat end faces 1458 of pins 1450 contact end walls 1195 ofpassage 1190 causing a transfer of force from the mounting pins 1450 topenetrating insertion members 1150 thereby driving the device thepenetrating insertion members 1150 and the implantation members 1110into the bone 205.

[0102] The fixation devices of the present invention and the combinationof the fixation devices with insertion members, and methods of usingsuch devices and combinations, of the present invention have manyadvantages. The advantages include providing a fast and routine way tofixate a matrix of tissue engineered tissue or other tissue. Thefixation devices and combination, because they eliminate the need forsuture knot tying, can be utilized in arthroscopic surgical proceduresthat require a minimum of surgical incisions and thus greatly reducepatient morbidity. In addition, the fixation devices and combinationhave been demonstrated to provide excellent matrix fixation withoutdamaging the surrounding normal cartilaginous tissue, unlike theconventional fixation of chondral defect matrices with traditionalsuture that must be passed through (and thus damage) the surroundingtissue.

[0103] Although this invention has been shown and described with respectto detailed embodiments thereof, it will be understood by those skilledin the art that various changes in form and detail may be made withoutdeparting from the spirit and scope of the claimed invention.

I claim:
 1. A graft fixation device, comprising: a first implantationmember, said implantation member having a longitudinal axis, a proximalend, a distal end, an outer surface, a longitudinal passagetherethrough, a proximal opening and a distal opening, wherein bothopenings are in communication with the passage; a second implantationmember, said implantation member having a longitudinal axis, a proximalend, a distal end, an outer surface, a longitudinal passagetherethrough, a proximal opening and a distal opening, wherein bothopenings are in communication with the passage; a retention memberconnecting the first and second implantation members, the retentionmember having a central section, a first end section extending from thefirst implantation member and a second end section extending from thesecond implantation member; and, an insertion member extending from thedistal end of each implantation member, wherein the insertion member hasa proximal end, a distal end, a proximal opening, a and outer surfaceand a longitudinal passage in communication with the proximal opening,wherein said longitudinal passage has a distal blind end, and whereinthe longitudinal passage of each insertion member is in communicationwith the longitudinal passage of the respective implantation members. 2.The device of claim 1 additionally comprising at least one wing memberextending from the retention member.
 3. The device of claim 1, whereinthe implantation members have a series of ridges extending from theouter surfaces thereof.
 4. The device of claim 1, wherein the retentionmember comprises a semicircular configuration.
 5. The device of claim 1,wherein the implantation members have a substantially cylindricalconfiguration.
 6. The device of claim 1 wherein the insertion membercomprises a bioabsorbable material selected from the group consisting ofpolylactic acid, polyglycolic acid, tricalcium phosphate, calciumphosphate, tetracalcium phosphate and hydroxyapatite, and copolymers,mixtures and blends thereof.
 7. The device of claim 1 wherein theinsertion member comprises a biocompatible material selected from thegroup consisting of titanium, stainless steel, ceramic, polysulfone,acetal, and Nitinol.
 8. The device of claim 1 wherein the fixationdevice comprises a bioabsorbable polymer.
 9. The device of claim 1wherein the fixation device comprises two opposed wing members extendingfrom the retention member.
 10. The device of claim 1 wherein theimplantation members comprise a cylindrical shape having a distallyextending frustoconical end.
 11. The device of claim 1, wherein theinsertion members have a conical configuration with a distally extendingtip portion.
 12. A method of mounting a matrix to a bone, the methodcomprising: providing a graft fixation device comprising: a firstimplantation member, said implantation member having a longitudinalaxis, a proximal end, a distal end, an outer surface, a longitudinalpassage therethrough, a proximal opening and a distal opening, whereinboth openings are in communication with the passage; a secondimplantation member, said implantation member having a longitudinalaxis, a proximal end, a distal end, an outer surface, a longitudinalpassage therethrough, a proximal opening and a distal opening, whereinboth openings are in communication with the passage; a retention memberconnecting the first and second implantation members, the retentionmember having a central section, a first end section extending from thefirst implantation member and a second end section extending from thesecond implantation member; and, an insertion member extending from thedistal end of each implantation member, wherein the insertion member hasa proximal end, a distal end, an outer surface, a proximal opening and alongitudinal passage in communication with the proximal opening, whereinsaid longitudinal passage has a distal blind end, and wherein thelongitudinal passage of each insertion member is in communication withthe longitudinal passage of the respective implantation members;accessing a bone; positioning a matrix member to the surface of thebone, said matrix member having a top surface and a bottom surface;mounting the graft fixation device to an instrument having a shafthaving a distal end, a proximal end, and distal mounting pins extendingfrom the distal end of the shaft, wherein the pins are engaged in thelongitudinal passages of the implantation members and insertion members;and, manipulating the shaft such that the insertion members are causedto penetrate the matrix and the bone, thereby causing the implantationmembers to engage the bone, and the retention member to engage thematrix such that at least a section of matrix is maintainedsubstantially in contact with the bone.
 13. The method of claim 12wherein the device additionally comprises at least one wing memberextending from the retention member.
 14. The method of claim 12 whereinthe implantation members have a series of ridges extending from theouter surfaces thereof.
 15. The method of claim 12, wherein theretention member comprises a semicircular configuration.
 16. The methodof claim 12, wherein the implantation members comprise a substantiallycylindrical configuration.
 17. The method of claim 12 wherein theinsertion member comprises a bioabsorbable material selected from thegroup consisting of polylactic acid, polyglycolic acid, tricalciumphosphate, calcium phosphate, tetracalcium phosphate and hydroxyapatite,and copolymers, mixtures and blends thereof.
 18. The method of claim 12wherein the insertion member comprises a biocompatible material selectedfrom the group consisting of titanium, stainless steel, ceramic, andNitinol.
 19. The method of claim 12 wherein the fixation devicecomprises a bioabsorbable polymer.
 20. The method of claim 12 whereinthe fixation device comprises two opposed wing members extending fromthe retention member.
 21. The method of claim 12, wherein theimplantation members comprise a cylindrical shape having a distallyextending frustoconical end.
 22. The method of claim 12, wherein theinsertion members have a conical configuration with a distally extendingtip portion.
 23. The method of claim 1, wherein the retention membercomprises an elliptical configuration.
 24. The method of claim 12,wherein the retention member comprises an elliptical configuration. 25.The device of claim 1 wherein the implantation member comprises abioabsorbable polymer selected from the group consisting of polylacticacid, polydioxanone, polycaprolactone, polygalactic acid, polyglycolicacid, and combinations thereof.
 26. The method of claim 12 wherein theimplantation member comprises a bioabsorbable polymer selected from thegroup consisting of polylactic acid, polydioxanone, polycaprolactone,polygalactic acid, polyglycolic acid, and combinations thereof.